Neurofeedback for Bipolar Disorder (NEUROFEED-BD)
Bipolar Disorder
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, Neurofeedback, fMRI, Residual symptoms, Emotion, Cognitive training
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with bipolar disorder I or II (DSM-5 criteria); Aged between ≥ 18 and ≤ 65; Absence of major mood episode for at least 3 months before inclusion (MADRS scores < 12; YMRS score < 10); Presence of residual depressive symptoms, as assessed by the MADRS (score > 5); Stabilized dose of mood stabilizer medication for at least 3 months before inclusion. Written consent Affiliation to a social security system Effective contraception for women of childbearing age Exclusion Criteria: Severe physical disorders that may be life-threatening; Major psychiatric (Axis 1) comorbidities except for anxiety disorders; Any current substance abuse except for tobacco or cannabis. Substance abuse will be defined by the DSM V criteria; Exclusion criteria applicable to MRI Panic disorder, claustrophobia, epilepsy Pace maker or neuronal stimulator, intraocular or intracerebral metallic foreign body, cochlear implant, cardiac valve or metallic surgical arterial material, non removable removable magnetizable metallic material Somatic disorder that may affect cognitive abilities and brain structures (e.g., HIV infection, MS, lupus, Parkinson's disease, epilepsy, dementia...); Ongoing non-pharmacological treatment: structured psychotherapeutic interventions (Cognitive Behavioral Therapy - CBT, Interpersonal and Social Rhythm Therapy - IPSRT) as well as brain stimulation techniques (Electroconvulsive Therapy - ECT, Transcranial Magnetic Stimulation - TMS, Deep Brain Stimulation - DBS); Subject included in clinical and / or therapeutic experimentation in progress. Patients under legal protection Prisoners Pregnancy Breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active feedback
Sham feedback
Group receiving "real" neurofeedback (NFB) (activity of the emotional brain network)
Group receiving "sham" NFB (activity from brain regions not implicated in emotion processing) to control for a potential placebo effect.